Method and apparatus for adjusting flexible areal polymer implants

ABSTRACT

A minimally invasive approach to adjusting the amount of support on an anatomical structure. The methods and apparatus described include the use of a tape for supporting an anatomical structure. Adjustment may be achieved by use of bulking agents applied either directly to the site or into a containment device located within proximity of the tape and such that it works in conjunction with the tape to support the anatomic structure. An alternative approach utilizes mechanical means for adjusting the effective length of the supporting arms of the tape used to support the anatomical structure.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 09/589,242, filed on Jun. 7, 2000, now U.S. Pat. No. 7,083,637 whichclaims the benefit of earlier-filed U.S. provisional patent application,Ser. No. 60/138,231, filed on Jun. 9, 1999, both of which are herebyincorporated by reference in its entirety herein.

BACKGROUND OF THE INVENTION

The present invention relates generally to a minimally invasive approachto adjust a flexible areal polymer implant for supporting an anatomicalstructure and further relates to an approach especially useful for usewith implants that support the urethra for treating female urinaryincontinence.

Women account for more than 11 million of incontinence cases.

Moreover, a majority of women with incontinence suffer from stressurinary incontinence (SUI). Women with SUI involuntarily lose urineduring normal daily activities and movements, such as laughing,coughing, sneezing and regular exercise.

SUI may be caused by a functional defect of the tissue or ligamentsconnecting the vaginal wall with the pelvic muscles and pubic bone.Common causes include repetitive straining of the pelvic muscles,childbirth, loss of pelvic muscle tone, and estrogen loss. Such a defectresults in an improperly functioning urethra. Unlike other types ofincontinence, SUI is not a problem of the bladder.

Normally, the urethra, when properly supported by strong pelvic floormuscles and healthy connective tissue, maintains a tight seal to preventinvoluntary loss of urine. When a woman suffers from the most commonform of SUI, however, weakened muscle and pelvic tissues are unable toadequately support the urethra in its correct position. As a result,during normal movements when pressure is exerted on the bladder from thediaphragm, the urethra cannot retain its seal, permitting urine toescape. Because SUI is both embarrassing and unpredictable, many womenwith SUI avoid an active lifestyle, shying away from social situations.

U.S. Pat. No. 5,112,344 describes a method and apparatus for treatingfemale incontinence. The surgical instrument for the application of afilamentary element into the body comprises a tubular shaft having ahandle at one end and a flexible needle slidably receivable in the shaftand adapted at one end to receive a filamentary element. The method oftreating female incontinence comprises looping a filamentary elementbetween the wall of the vagina and the rectus abdominis sheath in theanterior wall of the abdomen whereby it passes to each side of theurethra, adjusting the loop to bring the vaginal wall and the urethrainto the correct spatial relationship to the pubis allowing thedevelopment of scar tissue between the vaginal wall and the anteriorwall of the abdomen pubic symphysis and removing the filamentaryelement.

U.S. Pat. No. 5,899,909 discloses a surgical instrument comprising ashank having a handle at one end and connecting means at the other endto receive, one at a time, two curved needle-like elements which areconnected at one end to one end of a tape intended to be implanted intothe body. In practice, the tape is passed into the body via the vaginafirst at one end and then at the other end at one side and the other,respectively, of the urethra to form a loop around the urethra, locatedbetween the urethra and vaginal wall. The tape is extended over thepubis and through the abdominal wall and is tightened. The tape ends arecut at the abdominal wall, and the tape is left implanted in the body.U.S. Pat. No. 5,899,909 is incorporated herein by reference.

While implanting a tape, it is often difficult to determine the mostsuitable amount of support to provide to the urethral structure. Anoptimal amount of support is defined as that which provides relief fromincontinence and simultaneously provides for normal micturition. Even ifthe most optimal amount of support is provided during implantation, itis possible that the surrounding tissues will change during the healingprocess or simply due to aging. As a result, the optimal amount ofsupport is subject to change.

European Patent 0941 712 A1, José Gil-Vernet Vila, describes an approachto adjusting urethral support by use of an expandable containerimplanted remotely from the urethra and connected to a mesh supportingthe urethra. While this provides adjustment capabilities, the associatedsurgical procedure is invasive and complex. The container is alsocomplex and requires features to assure that the suspending threads arenot abraided. The container is preferably located in adipose tissue inthe abdominal region. The container's location exposes it to distortionwhenever there are external forces applied to the abdominal area. Thisin turn is expected to transiently change the degree of support to theurethra whereas it is desirable to provide a fairly constant level ofsupport. Since the mesh support is directly in contact with the urethra,the fluctuations of support to the urethra can become irritating to thesurrounding tissue.

U.S. Pat. No. 6,042,534, Gellman et al., describes the use of a visualindicator that may be radiopaque. However, there is no specificdescription of how to achieve this effect and makes no mention of itsuse with a tape support device. Further, the purpose of this indicatoris solely for assessment of the relative position of the sling used tosupport the urethra. Gellman is silent with respect to the need toadjust the sling after it is in place.

U.S. Pat. No. 5,611,515, Theodore V. Benderev et al., describes the useof a suture tensioning devices in conjunction with bladder necksuspension. These tensioners are used to adjust the tension on suturesused to hold a supportive sling in place on the bladder neck. Prior totying, sutures are appropriately tensioned by advancing the suturearound a suture tensioner and tying in a conventional manner.Thereafter, the suture tensioner is removed and the surgical siteprepared and closed in a conventional manner. While this technique isfine for establishing the initial tension to the sling, it does notallow for post implantation adjustment. Also, this approach is finewhere the sling is suspended with sutures or other filament means.However, such tensioning devices are unsuitable for tapes implanted suchas those associated with the GYNECARE TVT Tension-Free Support forIncontinence.

International Patent WO 98/31301 discloses an implantable continencedevice that consists of a hydraulic and mechanical component.

Therefore there is a need to be able to adjust the level of support tothe urethra in a less complicated manner and with no urethra-meshcontact. Further, the adjustment should be located in close proximity towhere the support is needed.

The present invention discloses devices and methods for adjusting thesupport of internal anatomical organs both during and afterimplantation. In particular, the invention is intended to be especiallyuseful for use with implants that support the urethra.

SUMMARY OF THE INVENTION

The invention overcomes the deficiencies of the prior art and providesfor an improved apparatus and method for adjusting the level of supportprovided to an anatomical structure by an implanted tape. The inventionfinds particular benefit to the treatment of female urinaryincontinence.

In particular the invention is useful with system for the treatment offemale stress urinary incontinence. The system provides a surgicalinstrument comprising a handle at one end and connecting means at theother end to receive, one at a time, two curved needle-like elements,each of which has a modified tip. The needle may have a constant orvarying diameter. Each needle connects at one end to separate ends of atape intended to be implanted within the body. In practice, a first endof the tape is passed, via one of the curved needles, into the body viathe vagina at one side of the urethra. The needle and first end of thetape pass over the pubis and through the abdominal wall. The secondneedle element connects to the second end of the tape and passes intothe body via the vagina at the opposite site of the urethra from thefirst end of the tape thereby forming a loop or sling around the urethrawith the tape. The second end of the tape is extended over the pubis andthrough the abdominal wall. The tape ends are cut at the abdominal wall,and the tape is left in the body.

The invention further provides for a single curved needle element havinga modified tip. The needle may have a constant or varying diameter andfurther provides for a easy attachment means enabling the surgeon toconnect both the first and second tape ends to the single needle toperform the above-stated procedure.

In both embodiments, the invention provides for devices and methods foradjusting the level of support provided to the urethra by an implantedtape. Two approaches are offered. One relates to the use of bulkingagents, both contained and directly injected into surrounding tissues.In this approach, detectable markers are provided to guide the clinicianduring the injection process. The second approach offers mechanicalmeans of adjusting the effective length of supporting arms of a tapeused to support the urethra. These devices include threadedly adjustableconstructions.

The object of the invention is to provide a method for adjusting thelevel of support to an anatomical structure offered by an implantedtape.

An advantage of the invention is that it provides for continualadjustment capabilities to an implanted tape for supporting ananatomical structure.

These and other features and advantages of the present invention willbecome apparent from the following more detailed description, when takenin conjunction with the accompanying drawings which illustrate, by wayof example, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a view of the needle for use with the tape mesh;

FIG. 2 a is a side view of two needles and a tape interconnecting theneedles;

FIG. 2 b-d are alternate embodiments of the tape and connecting meansbetween the tape and needle;

FIGS. 3 a-g embodiments of means for attaching the tape to the needle;

FIGS. 4 a-f are alternate embodiments providing an expandable containerassociated with the tape mesh;

FIGS. 5 a-c are alternate embodiments for providing mechanical adjustingmeans to the tape mesh;

FIGS. 6 a-h illustrate diagrammatically several surgical steps of themethod utilizing two needles according to the invention to treat SUI;

FIGS. 7 a-h illustrate diagrammatically surgical steps of the methodutilizing one needle according to the invention to treat SUI;

FIG. 8 is diagrammatic representation illustrating direct bulkingbetween the tape and urethra; and

FIG. 9 is a representation of a detectable target ring implanted in thetape.

DETAILED DESCRIPTION OF THE INVENTION

Before explaining the present invention in detail, it should be notedthat the invention is not limited in its application for the treatmentof female incontinence or use to the details of construction andarrangement of parts illustrated in the accompanying drawings anddescription, because the illustrative embodiments of the invention maybe implemented or incorporated in other embodiments, variations andmodifications, and may be practiced or carried out in various ways.Furthermore, unless otherwise indicated, the terms and expressionsemployed herein have been chosen for the purpose of describing theillustrative embodiments of the present invention for the convenience ofthe reader and are not for the purpose of limiting the invention.

The invention discloses an apparatus and method for treating SUI. A tapeis passed through pelvic tissue and positioned underneath the urethra,creating a supportive sling. The tape provides a structure means fortissue ingrowth and thereby provides a newly created body tissuesupporting means for the urethra. When pressure is exerted upon thelower abdomen, such as during a cough or sneeze, the tape providessupport to the urethra, allowing it to keep its seal and prevent theunwanted discharge of urine.

Referring to FIGS. 1 and 2 a, the surgical instrument comprises aneedle-like element 10 that attaches to a mesh tape 12. Needle element10 defines a certain radius R to perform the surgical procedurediscussed herein. The distal end of needle element 10 terminates at aconical section 14 having a tip 16. Alternate configurations, such as ablade-like, arrow or burr tips are also possible.

Preferably, tip 16 is blunt, wherein the tip 16 has a radius of about0.6 millimeters. A blunt tip is preferred since it is less likely tostick in bone or penetrate bladder wall tissue or blood vessel walltissue as will be appreciated from the method of implanting the tape asdescribed below.

The proximal end of needle 10 terminates in an attachment segment 20that is adapted to mate and lock into a handle 411 as disclosed in U.S.Pat. No. 5,899,909, previously incorporated herein by reference.

Disposed between cone portion 14 and segment 20 is a curved shaftsegment 18 having a distal end 17 and a proximal end 19. The shape ofshaft 18 extends substantially a quarter of a circle in order to followsubstantially the profile of the pubis between the vagina and theabdominal wall. For the purposes of the method as will be discussed inmore detail below, shaft 18 has a preferred radius R of about 106millimeters. The diameter of the curved shaft segment 18 may be constantor the diameter of segment 18 transitions from a smaller diameter atdistal end 17 to a larger diameter at proximal end 19. The minimumdiameter of distal end 17 may be as small as 0.5 mm due to the minimalstresses at this point. The minimal diameter of proximal end 19 is about4 mm. Preferably, the diameter at the proximal end is about 6 mm, andreduces in a continuous manner to a diameter of about 3 mm at the distalend 17. This design takes into account, that in the method to implantthe tape 12, the bending stresses are lowest at distal end 17, while thebending stresses are highest at the proximal end 19. Stated differently,during the procedure, the inner bending moment at distal end 17 isnegligible, while the inner bending moment at the proximal end 19 issubstantial.

Needle 10 is preferably has a circular cross section and is made from amaterial that is compatible with the human body. It is also preferredthat needle 10 is made from a material that can be autoclaved to enablemultiple surgical procedures of needle 10. Preferably, needle 10 is madefrom 303 stainless steel. The surface of shaft 18 may be smooth,preferably polished, to facilitate penetration of the soft tissue.Alternatively, the surface of needle 10 may have a somewhat roughersurface. A rougher surface would result in slightly additional tissuetrauma, which in turn stimulates fibroblast activity around the tape 12.

Needle 10 may be manufactured as a single, continuous unit, oralternatively, curved portion 18 may be manufactured separately fromlinear portion 20. In this manner the two pieces would attach using anyconventional attaching means, such as, screwing, or other conventionalmeans as is known to those skilled in the art.

Referring to FIGS. 2 a-d, tape 12 comprises any tissue-compatiblesynthetic material, or any natural material, including, but not limitedto, autologous, allograft, xenograft, a tissue engineered matrix, or acombination thereof. An exemplary synthetic material is PROLENE®polypropylene mesh, a mesh having a thickness of 0.7 mm and openings ofabout 1 mm manufactured by Ethicon, Inc., Somerville, N.J., U.S.A. Thismaterial is approved by the U.S. Food and Drug Administration forimplantation into the human body. A still further embodiment of the tape12 is a combination of a synthetic material 11 and a natural material 13centered between the synthetic material 11 as shown in FIGS. 2 b-c. Astill further embodiment of the tape 12 includes a combination ofsynthetic material 11 and natural material 13, whereby the naturalmaterial is placed over or incorporated within a generally centralportion of the synthetic material 11. One advantage of the tapeconfigurations is that natural material 13 is along the center region oftape 12 so that after installation of tape 12, natural material 13 ispositioned below the urethra and eliminates possible erosion issues atthe interface of the urethra and tape. Natural material 13 may beconnected to the synthetic material 11 by means of sewing, abio-compatible glue, cell culturing techniques or other known means.

Tape 12 may be of any convenient shape that suits the intended purposeof the invention. An exemplary width is about 1 cm and the length wouldbe dependent upon the size of the female undergoing the procedure. Tape12 may be single or double ply, generally planar in structure, ortubular (FIG. 2 d) to provide additional supporting strength and moresurface area on which tissue fibers may attach. Moreover, tape 12 mayconsist of different types of material, such as a bioabsorbable andnon-bioabsorbable material. Tape 12 may also be coated with anantimicrobial additive to prevent or minimize infection and a lubricouscoating, for example, a bioabsorbable hydrogel, to facilitate the tapepassing through the tissue as discussed below. Preferably, tape 12 iscovered by a removal plastic sheath as disclosed in U.S. Pat. No.5,899,909. The tape may also be made radio-opaque and/or of acontrasting color to the body tissue to allow for future diagnosticvisualization.

Referring to FIGS. 4 a-f, tape 12 is further modified to include anexpandable container or chamber 100 positioned on the tape 12 so thechamber 100 is located between the urethra and tape surface after thesurgical procedure, discussed below. The container 100 serves to limitmigration and/or resorption of the bulking agent. Further, the chamber100 expands or contracts by either injecting into or extracting bulkingmaterial from the chamber 100.

The container 100 may be made of a biocompatable material such as ahydrogel (i.e., crosslinked methacrylic-PEG esters, PHEMA, PMMA,phospholipid-like methacrylic polymers, radiation crosslinked PEO orPEG), polypropylene, polyester, silicone, or polyurethane. The containermay be an integral part of the tape or may be slidably attached so thatits position is such that it will work in unison with the tape insupporting the urethra. This should be near the center of the mesh sothat after implantation, container 100 is positioned below the urethralarea. Optionally, container 100 has a touchable internal valve element101 to permit the surgeon to palpatate the area prior to injecting orremoving the bulking agent. Alternatively, the bulking agent may beinjected and removed via a two-way external port 102. When a bulkingagent is injected into container 100 the tissue between mesh and urethrawill expand. This results in two effects; a simple vertical lifting dueto expansion and a vertical lifting due to stretching the outside of themesh. A suitable bulking agent may be water or saline.

Preferably, container 100 has no voids when empty and has a height ofabout 0.5 cm to about 2 cm and a length from about 2 cm to about 4 cm.Container 100 may be an cube-like expandable element of FIG. 4 a, or adome-shape of FIG. 4 b. The container 100 also includes a foot portion103 suitable for attachment to tape 12. Attachment may be achieved byincorporating the tape into the foot with the hydrogel being on bothsides of the tape as shown in FIG. 4 b. Foot portion 103 is preferredwhen the tape is a polypropylene mesh since polypropylene materials donot accept adhesive material. This configuration is preferred becausecontainer 100 increases the effective bending stiffness of the tape 12in the area of the container's attachment.

Alternatively, container 100 may comprise two chambers 100 a, 100 b influid communication with each other. Alternatively, the two chambers 100a, 100 b may be separate and effectively two containers. However, theymay be linked together by a common injection port. This configurationsallows for tissue expansion both underneath and lateral to the urethra.

The addition of container 100 to the mesh 12 acts to increase theeffective bending stiffness of the mesh 12 in the area of the attachmentof container 100. The increased bending stiffness provides additionalsupport to the urethra when the mesh 12 is implanted. The bendingstiffness further increases when the container 100 is filled withbulking agents

If container 100 is semi-permeable, the injected bulking agent can bedesigned to take advantage of osmotic tension to assure adequate fillvolume. Similarly, a container 100 fabricated with a hydrogel may have aslight osmotic tension adjustment effect. Further, drug delivery can beachieved by diffusion of the injected material from within the containerto the surrounding tissues.

EXAMPLE 1

A container 100 was manufactured utilizing a commercially available 6cm×4 cm tissue expanding device available from Mentor Deutschland GmbH,catalog number 350-5301M. The tissue-expanding device includes a remotetwo-way injection port 102 attached to one end. The tissue-expandingdevice was cut in the longitudinal direction to a width of 2 cm. Theupper and lower walls were temporarily sealed together along the cutlengths using cyanoacrylate glue and later permanently sealed using thesilicon adhesive, below. This results in a container having a width ofapproximately 1.5 cm. A polypropylene mesh was placed on the container.A silicon adhesive (silicon monomer and a catalyst component) wasbrushed onto the mesh segment overlying the container and the underlyingcontainer and. After curing over night, the mesh was firmly attached tothe container. The expandable container with external port was easilyand reversible expandable. The manufactured container 100 provided theadded bending stiffness along the area of its attachment to the mesh.

EXAMPLE 2

A configuration similar to Example 1 except that the injection port isincorporated as an integral part of one side of the expandablecontainer. Container mounts to the mesh 12 by providing an opening 104in the mesh 12 for the introduction of the injection port 102 a as shownFIGS. 4 c-d.

FIG. 4 e discloses a double walled self-sealing container 100 thateliminates the need for a separate injection port. Container 100comprises an inner chamber 100 c that preferably contains a centrallylocated plastic or metal barrier 105 to prevent needle penetrationthrough the far wall while injecting the bulking agent. While injectingthe bulking agent using, for example, a needle, puncture holes arecreated in the walls of the inner and outer chamber 100 c, 100 d,respectively. After removal of the injecting device, exact alignment ofthe inner and out chamber puncture holes is shifted. This shift resultsin effectively sealing the injection site.

Alternatively, a single walled self-sealing container may be used. Theinner layer of such a container may have a soft plastically deformablecoating. The coating acts to fill-in any injection puncture siteresulting in sealing the container.

Tape 12 may be further modified to include a mechanical adjustment meansto adjust the tape 12 after it has been implanted as discussed below.The mechanical adjustment means incorporate a suture 106 and 106 apreferably located on either side of the central portion of the tape 12as shown in FIGS. 5 a-c. Sutures 106 and 106 a can be used incombination with a one-way suturing retaining device 108 as is disclosedin U.S. Pat. No. 5,669,935, which is incorporated in its entirety byreference herein. Retaining device is anchored to tape 12 using anybiocompatible adhesive or attachment as is known to those skilled in theart. Another means includes a tie-wrap-type mechanism to adjust thelength of one or both sides of the tape 12 in near proximity to theurethra 54 and similarly positioned as sutures 106, 106 a. In eitherinstance, the sutures 106, 106 a or tie wrap remain accessible throughthe incision in the vagina, discussed below, for a period of time aftertape implantation. Tape adjustment would be suitable for a number ofdays following the procedure before serious tissue ingrowth occurs.Afterward, the exposed sutures or tie-wrap may be cut.

In one embodiment tape 12 may be attached to needle segment 20 by meansof tying, gluing or other suitable attaching means. Preferably, abio-compatible heat shrink tube fixes tape 12 onto needle portion 20,FIG. 2 a. In a further embodiment, as shown in FIGS. 2 b-d and 3 a-h,needle 10 and tape 12 are further configured to enable easy attachmentand detachment of tape 12 to and from needle 10 by the surgeon duringthe operation. This embodiment allows for the use of a single needle forthe procedure. This embodiment also allows for the use of a tapeconstructed, at least in part, of natural materials, which are otherwisenot suitable in the pre-affixed embodiment due to the inability of thenatural material to survive extended periods in inventory.

In one embodiment, shown in FIGS. 3 a-c, shaft 18 provides for a notchor slot 40 to slidably receive connecting tabs 32 and 32 a that areattached at either ends of tape 12 (FIGS. 2 b-d). Preferably, slot 40extends through curved shaft 18 and is further located at the distal end17 of needle 10 so that tape 12 may be disconnected from needle 10immediately after needle 10 penetrates the abdomen wall, discussedbelow.

Tab 32 may be constructed from any bio-compatible material, such asplastic or metal. Tab 32 can be any shape, such as a square or arrowshape, so long as tap 32 can be securely inserted into notch or slot 40.FIG. 3 b-c illustrates tab 32 having two spring arms 33 and 33 a thatwhen inserted into slot 40 expand and securely fasten tab 32 within slot40. Tab 32 may be attached to tape 12 in any number of convenientmethods as previously discussed and well known to those skilled in theart.

FIG. 3 d-e illustrates a two-tier slot 40, wherein tab 32 and springelement 33 b slide into the lower tier which holds tab 32 in place.Alternate means of capturing tab 32 within slot 40 are available as iswell known in the art.

FIGS. 3 f-g illustrate an alternate embodiment of affixing tape 12 tothe distal end 17 a of needle 10. A detachable blunt tip 16 d having aconnecting post 15, attaches to the distal end 17 a by means of amounting hole 15 a to accept post 15. Post 15 may be securely attachedto hole 15 a either by compression fit, mating threads or otherconvenient attachment methods. Distal end 17 a further defines a groove23 of varying depth to allow the end of tape 12 connected to post 15 totransition from within hole 15 a to the exterior of needle 10. Alongwith the embodiment of FIGS. 3 a-e, this embodiment allows the surgeonto affix tape 12 to needle 10 just prior to the surgical procedure. Oneadvantage is the ability to use a tape 12 constructed of, at least inpart, a natural material 13.

As would be appreciated by one skilled in the art, there exist multiplemeans for detachably connecting the tape to the needle. Alternateembodiments would include tying the ends of tape 12 to form a knot andsecurely inserting the knot into a V-type groove in shaft 18.Alternately, a diagonal slit in shaft 18 could accept tape 12 or asuture extending from tape 12.

The surgical procedure for implanting tape 12 using two needles is shownin FIGS. 6 a-h utilizing the needle embodiment illustrated in FIGS. 1and 2 a. In the figures the relevant parts of the female lower abdomenare disclosed, the vagina being 50, the uterus 52, the urethra 54, thepubic bone 56, the urinary bladder 58 and the abdominal wall 60. Thefirst needle 10 a penetrates the vaginal wall, an incision having firstbeen made in the wall to create a tissue flap. The needle is attached tohandle 411, and, the surgeon guides needle 10 a through the vaginal walland through the soft tissue on one side of the urethra 54, the needlethen according to FIG. 6 b being passed close to the back of the pubicbone 56, through additional layers of fat, muscle and fascia, and thenthrough the abdominal wall 60 above the pubic bone 56. An incision canbe made through the abdominal wall for the passage of the needletherethrough. The handle 411 is disconnected from needle 10 a, FIG. 6 c,and the needle 10 a along with tape 12 are withdrawn from the abdomenwall by means of forceps, FIG. 6 d.

Referring to FIG. 6 e, needle 10 b is now attached to handle 411. Thesurgeon passes needle 10 b through the incision in the vaginal wall andthrough the soft tissue, again, on the opposite side of the urethra thanthe previous end of tape 12. Needle 10 b passes close to the back of thepubic bone, through additional layers of fat, muscle and fascia, FIG. 6f, and then through the abdominal wall above the pubic bone andwithdrawn, FIG. 6 g.

FIGS. 7 a-g illustrate an alternate method of implanting tape 12 using asingle needle 10. Tape 12 is attached to needle 10 by means of springtab 32 as shown in FIGS. 3 b-c. Needle 10 penetrates the vaginal wall,an incision having first been made in the wall to create a tissue flap.The surgeon guides needle 10 through the vaginal wall and through thesoft tissue on one side of the urethra 54, the needle then according toFIG. 7 b being passed close to the back of the pubic bone 56, throughadditional layers of fat, muscle and fascia, and then through theabdominal wall 60 above the pubic bone 56. An incision can be madethrough the abdominal wall for the passage of the distal end 17therethrough. Needle 10 only continues to pass through the abdominalwall until tap 32 may be disconnected from needle 10, FIG. 7 c. To doso, the surgeon simply pushes tab 32 through slot 40 using anappropriate instrument and cuts tab 32 pulls out tab 32 using forceps.Tab 32 may then be cut off and tape 12 may be pulled out of theabdominal wall to allow the surgeon additional length for the procedure.Needle 10 is then removed from the patient along the same path that itentered, but in the opposite direction, FIG. 7 d. Alternatively, needle10 may be disconnected from handle 411 and pulled out through theabdomen wall 60 using forceps as discussed with regard to the two needleprocedure.

Needle 10 is now attached to the opposite end of tape 12 using connectortab 32 a. The surgeon passes needle 10 through the incision in thevaginal wall and through the soft tissue on the opposite side of theurethra than the previous end of tape 12, FIG. 7 e. Needle 10 passesclose to the back of the pubic bone, through additional layers of fat,muscle and fascia, FIG. 7 f, and then through the abdominal wall abovethe pubic bone. Needle 10 continues to pass through the abdominal wallonly until tab 32 a may be disconnected from needle 10, FIG. 7 g. Tape12 may be pulled out of the abdominal wall to allow the surgeonadditional length for the procedure. Needle 10 is then removed from thepatient along the same path that it entered, but in the oppositedirection. Alternatively, needle 10 may be disconnected from handle 411and pulled out through the abdomen wall 60 using forceps.

Since both procedures may be performed using a local anesthesia, thepatient is able to provide feedback to the surgeon after tape 12 is inplace. Typically, the urinary bladder 58 is filled with a fluid, such aswater, using a catheter and the patient is requested to cough. Thesurgeon is able to determine the operation of the urethra and may adjustthe tape 12, as necessary, by adjusting the ends of tape 12 located atthe outside of the abdomen 60, FIGS. 6 h and 7 h. After adjustments, thesurplus tape at the abdomen is cut off, and the ends of the tape aresecured within the abdomen and the abdomen is closed. Likewise, theincision at the vaginal wall is closed whereby the tissue flap seals thetape between the urethra 54 and the wall of vagina 50.

Tape 12 is left in the body and forms an artificial ligament attached tothe abdominal wall that provides the support for the urethra as requiredin order to restore urinary continence to the patient.

At the end of either procedure disclosed in FIGS. 6 and 7, the surgeonmay perform a test procedure to determine the integrity of the urinarybladder. A hydraulic diagnosis of the bladder may be performed byplacing a rigid endoscope/sheath transurethrally and injecting fluidthrough the sheath into the bladder. The bladder is pressurized to aknown level, about 50 mm Hg as measured through the sheath. If thepressure is maintained, then the surgeon can be confident that thebladder has not been perforated. Conversely, if the bladder losespressure, steps can be taken to repair any defects.

Post-surgical adjustment of the tape may be accomplished by injectingbulking agents in the vicinity of the tape sling so as to effectadditional support to the urethra. Preferably the bulking agent would beinjected at the top of the mesh so as to expand the tissue between meshand urethra (direct bulking) as shown in FIG. 8. This procedure may beused in combination with a tape 12 having a expandable chamber or usedalone. Suitable direct bulking agents include DURASPHERES, CONTIGEN,MACROPLASTIQUE as well as polytetrafluorethylene, and synthetic, naturalslowly absorbable or nonabsorbable materials. Bulking agents must bestable, biocompatible and, in the case of direct injection without acontainer, should be resistant to migration. The bulking agent may bedetectable (eg., radiopaque) such as the case with DURASPHERES or maycontain a contrast component that allows for visualization of the amountand location of the agent.

To inject a bulking agent into container 100 (FIGS. 4 a-f), the surgeonwould palpate the area to detect the injection site for the container,and if needed, a small incision in the vaginal wall may be made.Alternatively, markers may be either separate or an integral part of thecontainer or tape. For example, ultrasound may be used to provide guidedinjection. This may be achieved preferably by rectal placement of thetransducer. A suitable bulking agent may then be injected using onlylocal anesthesia, transvaginally or transurethrally.

The ultrasonic diagnostic detectability of the targeting region could beimproved by radiopaque beads if desired. Referring to FIG. 9, an x-raydetectable polypropylene (for example, Prolene, provided by Ethicon,Inc.) foil ring 109 may be used. An exemplary ring 109 has an innerdiameter of 0.5 cm and an outer diameter of 1 cm and a thickness of 0.5mm and contains six 1.5 mm diameter zirconiumdioxide beads (95% ZrO₂/5%Y₂O₃ provided by Mühlmeyer Mahlechnik, Germany) as radiopacifiers aroundan opening in the mesh 12. Ring 109 is affixed to the center of tape 12using ultrasonic welding. These x-ray radiopacifiers are suitableimplant materials and are also visible in ultrasound.

Ring 109 may also be used for x-ray-guided injection. After tapeimplantation, the area around the tape may be expanded with a bulkingagent using guidance provided by x-ray visualization. Exact positions ofthe target ring 109 and (and corresponding tape), radiopacified-filledurethra, bladder and bulking agent (for example, radiopaque DURASPHERES)may be determined through the use of computerized tomography.

It will be apparent from the foregoing that, while particular forms ofthe invention have been illustrated and described, various modificationscan be made without departing from the spirit and scope of theinvention. Accordingly, it is not intended that the invention belimited, except as by the appended claims.

1. A surgical device for treating female urinary stress incontinence comprising: a) a substantially flat tape for implanting into the lower abdomen of a female to provide support to the urethra; and b) an expandable chamber affixed to the tape along a portion of a length of said tape so that, when the tape is implanted, the expandable chamber is positioned substantially below the urethra and above the vagina, wherein the expandable chamber is expandable by injection of an injectable agent therein, wherein such expansion directly provides increased support under the urethra, and wherein the surgical device has an increased bending stiffness along the portion of the length of the tape to which the expandable chamber is affixed.
 2. The surgical device according to claim 1, wherein the injectable agent is a bulking agent.
 3. The surgical device according to claim 1, wherein the injectable agent is a fluid.
 4. The surgical device according to claim 1, wherein the expandable chamber is comprised of a hydrogel. 